The following data is part of a premarket notification filed by Aradigm Corp. with the FDA for Smartmist Asthma Managment System, Smartmist, Model Number Sm-100/smartmist Spirometry Airway, Model Number Sa-100.
| Device ID | K960593 |
| 510k Number | K960593 |
| Device Name: | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | ARADIGM CORP. 26219 EDEN LANDING RD. Hayward, CA 94545 |
| Contact | Diane Jachinowski |
| Correspondent | Diane Jachinowski ARADIGM CORP. 26219 EDEN LANDING RD. Hayward, CA 94545 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-05-10 |
| Summary: | summary |